Post Cesarean Pain
Conditions
Keywords
Postoperative pain, Cesarean, Ketorolac
Brief summary
This is a randomized controlled single blinded trial to compare the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.
Detailed description
Administration of a dose of ketorolac for postoperative pain management at end of cesarean is routine practice at our institution. This is a randomized controlled single blinded trial at The Ohio State University comparing a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room immediately after cesarean section. Potential study participants will be identified at the time of admission to Labor and Delivery unit. Inclusion criteria must be met, namely patient's age, mode of delivery via cesarean section. The decision for mode of delivery will be at the discretion of the primary obstetrics (OB) provider. Indications for cesarean delivery would be: scheduled cesarean due to history of previous uterine surgery including prior cesarean section, failed induction of labor, arrest of second stage of labor, non-reassuring fetal status. Patients will be approached for consent and enrollment when decision is made to proceed for cesarean section by their primary provider. Patients with allergy to Non-steroidal anti-inflammatory drugs (NSAIDs), history of opioid use disorder, chronic pain disorders, or undergoing an emergent Cesarean section, will be excluded from the study. Once the decision has been made by the primary obstetrics (OB) provider to proceed with cesarean delivery, participants will be randomized in to one of two groups: * Single dose of IV Ketorolac 30mg Vs. * Single dose of IV Ketorolac 60mg The intervention and primary outcome will take place over the span of 24 hour post-cesarean. Once enrolled and randomized, patients will be given either 60 mg or 30 mg of IV ketorolac at the end of the procedure. All other obstetric care will be at the discretion of the primary provider, including but not limited to pain management postoperatively. Analysis will be by intent to treat. The secondary outcomes will be collected during the hospital stay until discharge.
Interventions
DRUGKetorolac 30 Mg
Participants will receive single dose of intravenous (IV) Ketorolac 30mg
DRUGKetorolac 60 Mg
Participants will receive single dose of intravenous (IV) Ketorolac 60mg
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria: * Pregnant individuals aged 18-45 with a viable single or twin intrauterine pregnancy * Cesarean section as the delivery mode * Regional anesthesia (Spinal, Epidural, Combined Spinal Epidural) 2.
Exclusion criteria
* Known allergy or adverse reaction to Non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or ketorolac * Patients with peptic ulcer disease, preexisting kidney or liver disease * Hemodynamically unstable due to hemorrhage * Acute or chronic pain disorder * Physician/provider or patient refusal * Estimated blood loss \> 2000 mL * General anesthesia * Opioid use disorder * Emergent Cesarean delivery * Coagulation disorders * Active asthma * Patients weighing \<50 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the Morphine Milligram Equivalents (MME) Use in the First 24 Hours. Postoperatively After Cesarean Section | After cesarean surgery up to 24 hours. | Comparing the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the Morphine Milligram Equivalents (MME) Use During Hospital Stay. | After cesarean surgery during hospital stay up to 2-3 days. | Comparing the morphine milligram equivalents (MME) use during hospital stay postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. |
| Comparing Patient Reported Pain Score Assessment. | After cesarean surgery up to 24 hours. | Comparing patient reported pain score assessment on a scale of 0-10 in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. Pain scores postpartum from 0 to 10 based on the Defense and Veterans Pain Rating Scale (DVPRS). 0- No pain 1. Hardly notice pain 2. Notice pain does not interfere with activities 3. Sometimes distracts me 4. Distracts me, can do usual activities 5. Interrupts some activities 6. Hard to ignore, avoid usual activities 7. Focus of attention, prevents doing daily activities 8. Awful, hard to do anything 9. Can't bear the pain, unable to do anything 10. As bas as it could be nothing else matters |
| Comparing the Time to First Administration of Opioid Pain Medication Postoperatively. | After cesarean surgery up to 2-3 days. | Comparing the time to first administration of opioid pain medication postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. |
| Pain Score on Discharge Home | After cesarean surgery during hospital stay up to 2-3 days. | Comparing the pain score on discharge home in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. Pain scores postpartum from 0 to 10 based on the Defense and Veterans Pain Rating Scale (DVPRS). 0- No pain 1. Hardly notice pain 2. Notice pain does not interfere with activities 3. Sometimes distracts me 4. Distracts me, can do usual activities 5. Interrupts some activities 6. Hard to ignore, avoid usual activities 7. Focus of attention, prevents doing daily activities 8. Awful, hard to do anything 9. Can't bear the pain, unable to do anything 10. As bas as it could be nothing else matters |
| Number of Participants With Adverse Maternal Outcomes. | After cesarean surgery during hospital stay up to 2-3 days. | Evaluating adverse maternal outcomes (acute kidney injury, admission to intensive care unit, maternal death). |
| Evaluating Type of Skin Incision. | After cesarean surgery during hospital stay up to 2-3 days. | Evaluating type of skin incision (Pfannenstiel vs. Vertical Midline). |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants |
| Age, Continuous | 32.2 Years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
None listed